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This document is designed
to be used as an aid for those responsible for implementing and
maintaining a HACCP system. It’s scope might cover all parts of the
production/growing stage of the commodity, any subsequent handling,
processing or packaging of the product, as well as distribution,
catering, retail and consumer handling. A flow diagram of the logical
sequence for implementing HACCP is included in Appendix II.
.......Stage
1: - the haccp team
To fully understand the process and be able to identify all likely
hazards and CCPs, it is important that the HACCP team is made up of
people from a wide range of disciplines. There are a number of functions
that the team must cover:
· There must be a chairman to convene the group and to direct the work
of the team ensuring that the concept is properly applied. This person
must be familiar with the technique, be a good listener and allow all
participants to contribute.
· Someone with a detailed knowledge of the production processes (a
production specialist) is required to draw up the initial flow diagrams.
· Several specialists may be involved in the team, each with an
understanding of particular hazards and associated risks, e.g. a
microbiologist, a chemist, a QC manager, a process engineer.
· People, such as packaging specialists, raw material buyers,
distribution staff or production staff who are involved with the
process, and have working knowledge of it, may be brought into the team
temporarily in order to provide relevant expertise.
· The team's progress and results of the analysis should be recorded by
a technical secretary.
If any changes are made to composition or operational procedures, it may
be necessary to alter the CCPs or change methods of monitoring.
.......Stage 2: - describe the product
A full description of the product
should be prepared. This should include information relevant to safety
information, e.g. composition, physical/chemical structures of the raw
materials and the final product, the amount of water available for
microbial growth (aw), the amount of acid or alkalii in the
product (pH); any treatments that will eliminate or reduce the level of
micro-organisms such as heating, cooling, freezing, brining , smoking.
Information regarding how the product is to be packaged, stored and
transported should also be considered together with facts regarding
its’ shelf life and recommended storage temperatures. Where
appropriate labelling information and an example of the label should be
included. An example of a form that can be used by the team is included
in Appendix III.
.......Stage
3: - identify the products' intended use
How the product is intended
to be used is an important consideration, i.e. is it to be cooked before
eating? Consumers like to experiment with food so it is possible for
food to be consumed raw, even when the manufacturer recommends cooking
before consumption. All eventualities should be considered at this
stage. Target groups in the population should be identified to whom the
product may present a higher risk, e.g. the young, elderly, immuno-compromised,
or pregnant women.
.......Stage
4: - the process flow diagram
The first function of the team is
to draw up a detailed flow diagram of the process. The expertise of the
production specialist is important at this stage. Processes will differ
in detail in different plants, and an accurate flow diagram depends on
detailed knowledge of the process. An example of a process flow diagram
for Criol sausage is included in Appendix IV.
.......Stage
5: - on site verification of flow diagram
Upon completion of the process
flow diagram (PFD), members of the team should visit the manufacturing
area to compare what information is present on the PFD compared to what
actually happens during production. This is known as "walking the
line", a step by step practice to check that all information
regarding materials, equipment, controls etc. have been taken into
consideration by the team during the preparation of the process flow
diagram. Aspects such as time of production, deviations caused by
different shift patterns, startup, shut down, cleaning and especially
night shifts should be monitored.
.......Stage
6: - identification of hazards and consider any measures required to
control the
identified hazards
Effective hazard identification
and risk assessment are the keys to a successful HACCP. All real or
potential hazards that may occur in each ingredient and at each stage of
production should be considered. Potential hazards can be identified by
the following means:
· Aetiological information, collected by Public Health laboratories,
will provide data regarding factors known to have given rise to
outbreaks of food-borne illness for particular products.
· Technical information collated on all aspects of production, raw
material storage and handling, processing, storage, distribution and use
of the product. This should include looking at the hygienic design of
equipment and layout of the plant, hygiene and sanitation procedures in
the plant, and health and hygiene of personnel.
· Complaints records; shelf-life and challenge testing; modelling;
libraries; consultancy.
A list of some specific hazards that may be associated with a range of
food products is included in Appendix V. The list is by no means
exhaustive and should be used only as a guide. There is also a list of
bibliographic references at the end of this chapter. Microbiological
hazards have been listed according to severity, i.e. will they make the
consumer ill or are they life threatening? The severity of hazard is
based on the stringency plan in relation to degree of health hazard and
conditions for use presented by the ICMSF (1986). A similar approach can
be used for other hazards.
Analysis of hazards is ideally both qualitative and quantitative as it
needs to provide useful information on the potential severity of risks.
The risk expresses the chance of a hazard occurring and the severity
relates to the magnitude of the hazard. The resources allocated to
controlling the hazard will be dependent on these factors. Control
measures may control more than one hazard and more than one control
measure may be required to control a single hazard.
.......Stage
7: - determining ccps
All ingredients and each stage of
the process are taken in turn and the relevance of each identified
hazard is considered. The team must determine whether the hazard can
increase at this stage or whether it can be reduced, prevented or
eliminated. If the hazard can be reduced, controlled, prevented or
eliminated through exerting some form of control at a particular stage,
it is a CCP. A decison tree can be used to determine CCPs, and an
example of the Codex decision tree is included in APPENDIX VI. However,
the judgement and expertise of the HACCP team are the major factors in
establishing CCP.
It is important that all CCP are controlled. When deciding on the extent
to which the CCP will be monitored, a judgement of risk must be made so
that a level of concern can be ascribed to it. There are four levels of
concern:
(a) High concern - An expert judgement that without control there is a
life threatening risk.
(b) Medium concern - An expert judgement that there is a threat to the
consumer that must be controlled.
(c) Low concern - An expert judgement that there is little threat to the
consumer . It may still be advantageous to control it.
(d) No concern - An expert judgement that there is no threat to the
consumer.
The points where control can be exerted, but are not critical because of
low risk or severity, need less control and monitoring. If a hazard can
be controlled at more than one point, the most effective place to
control it must be determined.
.......Stage
8: - target levels or critical limits
The team must next identify means
by which to control the hazard at each CCP. These may include for
example: chlorine levels in wash water; temperatures during storage, use
of documented procedures. All must be documented as statements or
included as specifications in operating manuals. Critical limits and
target values should be stated wherever appropriate.
.......Stage
9: - monitoring procedures
Monitoring is the mechanism
for confirming that processing or handling procedures at each CCP are
under control. The method chosen for monitoring must be able to detect
any loss of control, and to provide information early enough for
corrective action to be taken and for loss of product to be avoided or
minimised.
Monitoring can be carried out by observation or (although preferably
continuous) by measurement on samples taken in accordance with a
statistically based sampling plan. Monitoring by visual observation is
basic but gives rapid results, and can therefore be acted upon quickly.
It is applicable to assessment of raw materials, worker hygiene, hygiene
and sanitation procedures, and processing procedures. The most common
measurements taken are time, temperature and pH. For raw materials
however, tests for toxins, additives, contaminants and microbiological
tests may also be requested and the supplier may be required to use
HACCP procedures.
......Stage
10: -corrective action
If monitoring indicates that criteria are not being met, or that the
process is out of control, corrective action must be taken as soon as
possible. The corrective action should take into account the worst case
scenario, but must also be based on the assessment of hazards, risk and
severity, and on the final use of the product.
The specific action will depend on the process. In a fruit and vegetable
processing system, this may included re-washing of fruit and vegetables,
altering the chlorine concentration of water, or re-cleaning of
equipment. However, the traceability system must permit the quarentining
of all potentially defetive product made while the critical limit was
being infringed.
......Stage
11: -verification
Once the HACCP plan has been
drawn up it must be reviewed before being installed, and regularly
reviewed once the system is operating. This might be a task of the
person within the company with the responsibility for Quality Assurance
(QA), e.g QA Manager. The appropriateness of CCPs and control criteria
can thus be determined, and the extent and effectiveness of monitoring
can be verified. Microbiological tests can be used to confirm that the
plan is in control and the product is meeting customer specifications. A
formal internal auditing plan of the system will also demonstrate an
ongoing commitment by the company to keeping the HACCP plan up to date,
as well as representing an essential verification activity.
Ways in which the system can be verified include:
· collecting samples for analysis by a method different from the
monitoring procedure
· asking questions of staff , especially CCP monitors
· observing operations at CCPs.
· formal audit by independent person
It is important to remember that the HACCP system is set up for a
particular formulation of product handled and processed in a given way.
......Stage 12: -documentation
Although not specifically
required by law, record keeping is an essential part of the HACCP
process. It demonstrates that the correct procedures have been followed
from the start to the end of the process, offering product traceability.
It provides a record of compliance with the limits set, and can be used
to identify problem areas. Furthermore, the documentation can be used by
a company as evidence of ..."Due Diligence Defence"...
required by the Food Safety Act 1990 (HMSO). An example of a control
chart that can be used to summarise the HACCP plan is given in Appendix
VII.
There will be documents recording the actual HACCP study, e.g. hazard
identification and selection of critical limits, but the bulk of the
documentation will be concerned with the monitoring of CCPs and
corrective actions taken. Record keeping can be carried our in a number
of ways, ranging from simple check-lists, to records and control charts.
Manual and computer records are equally appropriate, but most auditors
prefer to work from paper records.
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